PANTOPRAZOLE AMNEAL pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Pantoprazole

Authorization status:

Registered

Patient Information leaflet

PANTOPRAZOLE ACTAVIS CMI v2.0 1 of 5
PANTOPRAZOLE
ACTAVIS
®
_Pantoprazole _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
PANTOPRAZOLE ACTAVIS. It
does not contain all the
available information. It
does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking PANTOPRAZOLE
ACTAVIS against the
benefits this medicine is
expected to have for you.
Use PANTOPRAZOLE
ACTAVIS as directed and
follow the advice given in
the leaflet.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT
PANTOPRAZOLE
ACTAVIS IS USED FOR
The name of your medicine
is PANTOPRAZOLE ACTAVIS.
It contains the active
ingredient called
pantoprazole.
ULCERS
PANTOPRAZOLE ACTAVIS is
used to treat and help heal
duodenal and gastric ulcers.
Depending on the position
of the ulcer it is called a
gastric or duodenal ulcer. A
gastric ulcer occurs in the
stomach. A duodenal ulcer
occurs in the duodenum
which is the tube leading
out of the stomach.
These can be caused in part
by too much acid being
made in the stomach.
Most people who have a
peptic ulcer also have
bacteria called Helicobacter
pylori in their stomach.
When PANTOPRAZOLE
ACTAVIS is taken with
antibiotics the combination
therapy will kill the
Helicobacter pylori and let
your ulcer heal.
REFLUX DISEASE
PANTOPRAZOLE ACTAVIS is
also used to treat reflux
oesophagitis or reflux
disease. This can be caused
by "washing back" (reflux)
of food and acid from the
stomach into the food pipe,
also known as the
oesophagus.
Reflux can cause a burning
sensation in the chest rising
up to the throat, also
known as heartburn.
PANTOPRAZOLE ACTAVIS is
also used to prevent reflux
oesophagitis from coming
back.
ZOLLINGER-ELLISON SYNDROME
PANTOPRAZOLE ACTAVIS is
used to treat a rare
condition called Zollinger-
Ellison syndrome, where
the stomach produces very
large amounts of

Summary of Product characteristics

_Pantoprazole Actavis tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Pantoprazole Actavis PI v2.0
1 of 19
PANTOPRAZOLE ACTAVIS
_ _
_(PANTOPRAZOLE SODIUM SESQUIHYDRATE ENTERIC-COATED TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Pantoprazole sodium (as pantoprazole sodium sesquihydrate).
Molecular Wt. (sodium salt x 1.5 H
2
O): 432.4.
Molecular Formula: C
16
H
14
F
2
N
3
NaO
4
S.1.5 H
2
O
CAS Number (pantoprazole sodium): 138786-67-I.
DESCRIPTION
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric
secretion. It is a white to off white crystalline powder. Solubility
is low at neutral pH and
increases with increasing pH.
Pantoprazole Actavis tablets contain 40 mg of pantoprazole sodium (as
pantoprazole
sodium sesquihydrate) as the active ingredient. The tablets also
contain the following
excipients - sodium carbonate anhydrous, mannitol, sodium starch
glycollate (Type A),
methacrylic acid copolymer, calcium stearate, hypromellose, titanium
dioxide, purified
talc, macrogol 400, sodium lauryl sulfate and Kollicoat MAE 30 DP dark
yellow
(Proprietary ID No.
13185)
.
PHARMACOLOGY
Proton pump inhibitor.
_Pantoprazole Actavis tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Pantoprazole Actavis PI v2.0
2 of 19
Pantoprazole inhibits specifically and dose proportionately H
+
/K
+
-ATPase, the enzyme
which is responsible for gastric acid secretion in the parietal cells
of the stomach.
The substance is a substituted benzimidazole which accumulates in the
acidic
environment of the parietal cells after absorption. There, it is
converted into the active
form, a cyclic sulfenamide which binds to the H
+
/K
+
-ATPase, thus inhibiting the proton
pump and causing potent and long lasting suppression of basal and
stimulated gastric
acid secretion. As pantoprazole acts distal to the receptor level it
can influence gastric
acid secretion irrespective of the nature of the stimulus
(acetylcholine, histamine,
gastrin).
Pantoprazole’s selectivity is due to th